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Data, Freedom of Information releases and corporate reports
Information about the EU Regulations and their implementation in Northern Ireland
Fees payable to the MHRA for 2023 to 2024
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
Safety leaflet to help you understand the latest information about the effects of pregabalin during pregnancy.
How to make a payment to MHRA by credit or debit card or a bank transfer.
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
The process for applicants applying for a Paediatric Investigation Plan (PIP) modification or waiver.
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
The eMIT provides information about prices and usage for generic drugs and pharmaceutical products.
Detailed guidance on advertising and promoting medicines.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
How to change the ownership from one marketing authorisation (MA) holder to another.
Guidance on whether or not your product is a medical device.
Take care when using creams to treat dry skin conditions as they can easily dry onto clothing, bedding and bandages making them more flammable.
This document provides guidance on the data integrity expectations that should be considered by organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA.
How the MHRA makes decisions on what is a medicinal product (borderline products).
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
How the MHRA makes decisions on when a product is a medical device (borderline products), and which risk class should apply to a medical device.
Keep up to date with the latest information from the UK GLP monitoring authority.
Information about when you need to submit substantial amendments to a clinical trial including changes to the trial sponsor or legal representative, Investigational medicinal product certification and importation.
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